Microbial air sampler

ABSTRACT

An air sampler device has a top plate and a bottom plate, and receives a Petri dish between the top plate and the bottom plate. The top plate includes 283 substantially small holes. The bottom plate has a deepened center well formed in the top surface. Elongated slots are formed in the top surface which extend out from the well. The slots have distal ends which extend beyond the Petri dish. Air is drawn into the sampler by a vacuum tube through an air port which communicates with the center well. Air is pulled into the 283 holes in the top plate and strikes the capture material in the Petri dish. The air then travels up over the sides of the dish, into the distal ends, through the slots, and into the center well, where it exits out of the vacuum air port.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to a microbiological gas sampler, andespecially for sampling air. More particularly, the present inventionrelates to a microbial air sampler used in a controlled environment.

2. Background of the Related Art

A controlled environment is an area which is designed, maintained, orcontrolled to prevent particle and microbiological contamination ofproducts. Controlled environments include, for example, clean rooms andclean hoods. There are different levels of cleanliness in clean rooms,generally in the range of a Class 100 room (i.e., a room having no morethan 100 particles of 0.5 micron and larger, per cubic foot of air), toa Class 10,000 clean room.

Clean rooms are used for a variety of purposes, such as in themanufacture of pharmaceutical products and electronics, such assemiconductors. Often, clean rooms are used to work on extremelyexpensive and complex products, and it is not unusual that there bemillions of dollars worth of product in a clean room at any given time.Clean rooms have to maintain a high level of cleanliness, or risk largefinancial losses. If a product being developed or manufactured in aclean room becomes contaminated, the entire product in the clean roommust often be discarded.

Microbial air samplers are used to monitor the level of cleanliness (interms of viable contamination) in a controlled environment. One or moresamplers are positioned about the clean room to collect airborneparticulates and organisms (or microorganisms) such as bacteria andfungi. Samplers that run at high flow rates permit air to enter thesampler at such high flow rates that loss of smaller particulatescarrying microorganisms is normality (i.e., smaller particulates are notretained in the medium). At the same time high flow rate air samplersonly sample for a short time period and relay on a short snapshot of thecondition of the area. Samplers running at 28.3 LPM (liters per minute)must operate for a longer period of time than a unit running at 322 LPM.In doing this, they sample a broader spectrum of the drug fill time andpresent superior data as the sample time takes a larger snapshot of theoperation. Samplers that run at 28.3 LPM also provide the ability tocapture more smaller particulates that may be lost due to dynamic drag(or an umbrella affect) in higher flow rate units.

Air sampling systems are generally known, and an air sampling system isoffered by Veltek Associates, Inc. known as SMA (SterilizableMicrobiological Atrium) Microbial Air Sampler System. One such system isshown in U.S. patent application Ser. Nos. 12/068,483, filed Feb. 7,2008 and 12/402,738, filed Mar. 12, 2009, and the counterpart PCTpublished application WO2009/100184, the entire contents of which arehereby incorporated by reference. As noted in those applications, theair sampler system includes a controller connected to a vacuum pump tocontrol the flow of air to air sampler devices located in the cleanroom.

A prior art air sampler device 5 is shown in FIGS. 1-2, which is offeredby Veltek Associates, Inc. The air sampler device 5 includes a top plate10 with openings 11 and a bottom plate 14. The bottom plate 14 has acircular ridge 16 on the top surface, which receives a Petri dish 12.The underside of the bottom plate 14 has a circular channel 20 (bestshown in FIG. 2) which communicates with an air port 22. A metal coverplate 26 fits over the underside of the bottom plate 14, and a rubbergasket 24 is positioned between the bottom plate 14 and the cover plate26 to provide an airtight seal. Screws are used to secure the coverplate 26 and gasket 24 to the bottom plate 14. In addition, a circularrubber gasket (not shown, but having the shape of a washer) ispositioned on the top surface of the bottom plate 14 around the circularridge 16 to create a substantially airtight seal between the bottomplate 14 and the top plate 10.

In operation, a vacuum tube is attached to the air port 22. Air is thensucked in through the openings 11 located in the top plate 10, so thatthe air strikes a test medium contained in the Petri dish 12. The airthen exits the device 5 through holes 18 located on the ridge 16 of thebottom plate 14. The air passes into the channel 20, and exits throughthe air port 22. The entire device 5 is metal, except for the gasket 24,so that the device 5 can be sterilized by heat, steam, VaporizedHydrogen Peroxide (VHP) or Ethylene Oxide (ETO). At the end of thetesting period, the Petri dish 12 is removed and analyzed to determinethe level of cleanliness of the clean room.

The Petri dish 12 has a diameter of about 3.5 inches. The top plate 10has a diameter of 4.5 inches. There are twelve holes 11 positionedwithin about a circular area having a 3 inch diameter, and each hole 11has a diameter of about 0.5 inches. The sides of the top plate 10 andthe bottom plate 14 are smooth.

SUMMARY OF THE INVENTION

Accordingly, it is an object of the invention to provide a device forsampling viable cells in air. It is another object of the invention toprovide a microbial air sampler having an improved design which isentirely sterilizable by heat, steam, VHP or Ethylene Oxide (ETO) anddoes not include a gasket. It is yet another object of the invention toprovide a microbial air sampler which can accommodate current Petri dishshapes and sizes.

Accordingly, an air sampler device is provided having a top plate and abottom plate, which receives a Petri dish between the top plate and thebottom plate. The top plate includes 283 substantially small holes. Thebottom plate has a deepened center well formed in the top surface at thecenter of the bottom plate. Six elongated slots are formed in the topsurface with proximal ends which extend out from the central well, anddistal ends which extend beyond the Petri dish situated about the centerof the bottom plate.

In operation, air is drawn into the sampler device by a vacuum tubethrough an air port which communicates with the center well. Air ispulled into the 283 holes in the top plate and strikes the capturematerial in the Petri dish. The air then travels up over the sides ofthe dish and into the distal ends of the slots of the bottom plate. Theair then travels down the elongated slots beneath the dish, and entersthe center well. The air is then sucked through the air passageway holeand exits out of the vacuum air port.

These and other objects of the invention, as well as many of theintended advantages thereof, will become more readily apparent whenreference is made to the following description, taken in conjunctionwith the accompanying drawings.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is an exploded perspective view of the air sampler device inaccordance with the prior art;

FIG. 2 is a cutaway perspective view of the air sampler device of FIG. 1in accordance with the prior art;

FIG. 3 is a top perspective view of the air sampler device in accordancewith the preferred embodiment of the invention;

FIG. 4 is a bottom perspective view of the top plate of the air samplerdevice of FIG. 3;

FIG. 5 is top plan view of the bottom plate of the air sampler device ofFIG. 3 showing movement of air within the device;

FIG. 6 is a cutaway top perspective view of an assembled air samplerdevice of FIG. 3 showing movement of air within the device; and,

FIG. 7 is a top perspective view of an assembled air sampler device ofFIG. 3.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

In describing a preferred embodiment of the invention illustrated in thedrawings, specific terminology will be resorted to for the sake ofclarity. However, the invention is not intended to be limited to thespecific terms so selected, and it is to be understood that eachspecific term includes all technical equivalents that operate in similarmanner to accomplish a similar purpose.

Turning to the drawing, FIG. 3 shows the air sampler device 50 inaccordance with the preferred embodiment. The sampler 50 primarilyincludes a top plate 100 and a bottom plate 150, and a Petri dish 52 ispositioned between the top plate 100 and the bottom plate 150. Thesampler 50 is circular, though other suitable sizes and shapes can beutilized.

The top plate 100 has a top surface 102 and a central depressed portion104 which is depressed with respect to the top surface 102. The centerof the top plate 100 is machined out to form the depressed portion 104with a lip 108. And, as shown in FIG. 4, the underside of the top plate100 is machined out to form a vent plate 110 and an inner wall 106.Accordingly, the vent plate 110 is integral with the top plate 100.There are two hundred and eighty-three (283) holes 112 formed in thevent plate. The inner wall 106 extends from the top surface 102 (FIG. 3)downward into the interior of the top plate 100. A channel 107 is formedbetween the inner wall 106 and the side wall 114 of the top plate 100which act as a vacuum venture, whereby the vacuum is pulled through thetop of the sampler, directly to the nutrient media and the up and overthe Petri dish 52 sides.

The inner wall 106 extends downward into the center of the Petri dish 52to further prevent (in addition to the ridge 154) the Petri dish frommoving. The inner wall 106 is shorter than the sides of the Petri dish52, so that the sides of the dish 52 contact the top of the channel 107before the material in the Petri dish 52 contacts the inner wall 106. Inaddition, as best shown in FIG. 6, the inner wall 106 extends down intothe Petri dish 52. The inner wall 106 prevents the sides of the dish 52from moving, to keep the dish 52 properly centered on the bottom plate150.

The top plate 100 has at least one outer side 114. The side 114 hasridges 116 extending around the outer circumference of the top plate100. The ridges 116 make the top plate 100 easy to grip, so that a usercan easily remove and replace the top plate 100 with respect to thebottom plate 150. In addition, the outer sides of the bottom plate aresmooth, so that the user can easily differentiate between the bottomplate 150 and the top plate 100 when removing the top plate 100 from thebottom plate 150. The ridges 116 are particularly useful since users areoften required to wear gloves (in addition to garments, hoods, andbooties) at all times while inside the clean room. These features allowthe top plate 100 to be easily lifted off of the bottom plate 150without disturbing the bottom plate 150.

The bottom plate 150 has a top surface 152, and a ridge 154 extendingupward from the top surface 152 at a distance from the outer edge of thebottom plate 150. The ridge 154 creates an outer shelf 153 whichreceives the side 114 of the top plate 100. The outside lip of the ridge154 prevents the side 114 of the top plate 100 from moving off of thebottom plate 150. The ridge 154 also defines a receiving portion 155which receives the Petri dish 52. The inside lip of the ridge 154prevents the dish 52 from moving and keeps the dish 52 centered withrespect to the bottom plate 150 and the holes 112 in the vent plate 110of the top plate 100. Accordingly, the ridge 154 ensures that air comingin through the holes 112 in the vent plate 110 come into contact withthe material in the Petri dish 52.

A deepened central well 158 is also formed in the top surface 152 at thecenter of the bottom plate 150. Six elongated slots 156 are formed inthe top surface 152 at the receiving portion 155. The elongated slots156 extend out from the central well 158 through the receiving portion155 and the distal ends 159 of the slots 156 extend partly(approximately halfway) into the ridge 154. Thus, when the dish 52 ispositioned on the top surface 152 of the bottom plate 150, the dish 52covers the center well 158 and the slots 156, but does not cover thedistal ends 159. The slots 156 have a rounded cross section (which issubstantially a half-circle), and the distal ends 159 are also rounded,which facilitates air travel and prevents particles from clogging theslots 156. Accordingly, air can enter the distal ends 159 and travel inthe slots 156 beneath the dish 52 into the center well 158. The bottomof the well 158 is rounded to meet up with the side of the well 158,such that the well 158 does not have hard corners and the air can travelfreely without the corners collecting debris.

A vacuum air port 160 is positioned at the side of the bottom plate andcommunicates with an air hole 162. The air hole 162 extends through thebottom plate 150, from the air port 160 to the center well 158. Thevacuum air port 160 connects to a vacuum tube to draw air through thesampler 50.

The operation of the sampler 50 is best shown in FIGS. 5 and 6, wherethe arrows generally show the direction of travel of the air as it flowsthrough the device 50. A sterilized sampler 50 is introduced into theclean room, and the top plate 100 is removed. The Petri dish 52 isinserted onto the bottom plate 150, and the top plate 100 is replaced.The air flow is then initiated for a predetermined period of time. Airis drawn into the sampler device 50 by the vacuum tube through the airport 160. The central depressed portion 104 of the top plate 100 allowsthe air to sit before being sucked into the sampler 50. The depression104 counteracts the turbulence which might result when a person walksclose to the sampler 50 or crates a current of air that may otherwisedisturb entry of the air and microbe carrying particulates. This, inturn, creates a more laminar and isokinetic flow of air through theholes 112. The equal velocity of air flow assures a betterrepresentative sampling of particulates in the air as airflowsymmetrically enters the sampler.

Once the air enters the holes 112 in the top plate, it strikes thecapture material in the Petri dish 52. The air then travels up over thesides of the dish 52 and into the distal ends 159 of the slots 156 ofthe bottom plate 150. The air then travels down the elongated slots 156beneath the dish 52, and enters the center well 158. The air is thensucked through the air passageway hole 162 and exits out of the vacuumair port 160. Once the predetermined period of time (which can be from10-60 minutes or longer) has lapsed, the air flow is turned off. The topplate 100 is then raised, and the Petri dish 52 is removed for testing.The sampler 50 can then be sterilized, if desired, and a new Petri dish52 introduced.

Accordingly, the air port 160 is in flow communication with thepassageway 162, which is in flow communication with the well 158. And,the well 158 is in flow communication with the center well 158, which isin flow communication with the elongated slots 156. The distal ends 159of the slots 156 are in flow communication with air entering the holes112 in the top plate 100.

It is noted that a rubber gasket is not utilized between the shelf 153of the bottom plate 150 and the side 114 of the top plate 100. The shelf153 and the side 114 are machined to a tolerance level which, togetherwith the weight of the top plate 100, becomes locked together with theforce of the vacuum and substantially prevents any air from enteringthrough the interface between the shelf 153 and the side 114. Inaddition, it is noted that the current invention eliminates the need forany material, such as a gasket, which might otherwise becomecontaminated, by reducing the number of metal-on-metal contact points.The entire device is substantially airtight, without the need of agasket to seal any metal-on-metal contact points. The entire device 50can be sterilized by heat, steam, VHP or ETO.

Furthermore, because the holes 112 in the top plate 100 are small, theelongated slots 156 and distal ends 159 can be made larger whileretaining a high air flow rate through the holes 112. By having largerslots 156, distal ends 159, center well 158 and hole 162, the device 50is less susceptible to becoming clogged. Though six slots 156 areprovided in the illustrated embodiment, fewer or more slots can beprovided, though preferably the slots are equally spaced about the Petridish so that the distal ends uniformly draw air from the dish.

In accordance with the preferred embodiment of the invention, the ventplate 110 has a diameter of approximately 2.5 inches and a thickness of0.0600 inches. The size (i.e., diameter) of the vent plate 110 issubstantially smaller than the size (i.e. diameter) of the Petri dish52, to reduce the desiccation or drying of the edges of the nutrientmedia. The preferred ratio is about 3:4 (i.e., 2.5 inch diameter for thevent plate 110 to a 3.25 inch diameter for the Petri dish), or that thevent plate is no larger than about 75% of the size of the Petri dish. Alarger ratio creates results in an air speed which adversely affects anuneven part of the media plate since the media plate is poured agar(nutrient media), which sometimes moves up the sides of the Petri dish52 which becomes dried.

Each hole 112 has a diameter of about 0.0070 inches (0.1778 mm), whichis approximately 0.00078% of the size of the vent plate. Since there are283 holes over the 2.5 inch diameter plate 110, the holes 112 accountfor approximately 0.22% of the area of the vent plate 110. The holes 112are positioned in 9 concentric rings at the following diameters: 0.0 (1hole), 0.40625 (10 holes), 0.65625 (15 holes), 0.90625 (20 holes),1.15625 (26 holes), 1.40625 (31 holes), 1.65625 (37 holes), 1.90625 (42holes), 2.15625 (48 holes), and 2.40625 (53 holes). It should beappreciated, however, that the size of the holes 112 can vary within thespirit of the invention, and the number of holes 112 may be more or lessthan 283. Preferably, however, there are at least 100-150 holes, andmore preferably at least 200 holes, with each hole being 0.007-0.009inches in diameter. Preferably, however, the holes 112 comprise lessthan about z1%, of the surface area of the vent plate 110 (i.e., thearea in which the holes are located).

By having small holes 112 in the top plate 100, air is drawn into thesampler 50 at a high flow rate (about 67.20 m/s per hole) and volume(about 1.67E-06 m³/s per hole), while keeping the flow rate at 1 CFM (or28.3 cubic liters per minute) at the air port 160 to provide a longersampling time. The flow rate of the air as it is drawn into the holes112 is about 28.3 LPM or 1 CFM or through each hole 0.1 is LPM. Thetotal for the top plate 100 is about 0.000472 m³/s. Particle sizes ofabout 0.2-9 microns may be reflected, while 10+ microns are deposited.Particles of 0.2-9.0 microns can be swept away from dynamic drag if theairflow is too high, so that airflow is reduced to capture those smallerparticulates. The sampler 50 has an efficiency loss of about 5.6-7.2%,which is much lower than conventional samplers which have an averageloss of approximately 20%.

The faster air flow at the holes 112 provides higher capture realizationin the material located in the Petri dish 52 since the particles can'tbounce off of the capture material. The sampler 50 will captureparticles which are approximately 0.5-30 μm in size. The well 158 is oneinch in diameter, and about ⅜ inches deep from the top surface 152. Theslots 156 are about 0.25 inches wide and the distal end 159 of the slots156 extends ⅛ inch into the ridge 154. The ridge 154 is 0.25 incheswide. Though six slots 156 are provided, more or fewer slots can also beutilized. The sampler 50 can be utilized with the sampling system shownin WO2009/100184. The capture material in the Petri dish 52 is usually abacterial growth medium, such as trypticase soy agar, though anysuitable medium can be used. The dish 52 has a diameter of 3.5 inchesand can retain 18, 25 or 32 ml of capture material, though the dish 52can be any suitable size.

Further to the preferred embodiment, the top plate 100 and the bottomplate are both circular, with a diameter of approximately 4.5 inches.The completely assembled sampler device 50 is shown in FIG. 7. Thebottom plate 150 is sized and shaped substantially the same as the topplate 100, though the top plate 100 can be slightly larger to furtherassist in removing it from the bottom plate 150 without disturbing thebottom plate 150. Though the device 50 is shown as circular, othershapes may be used. And, the device 50 may be substantially larger orsmaller than the dimensions provided.

The plates 100, 150 are preferably made of stainless, anodized aluminum.The bottom of the sides 114 of the top plate 100, and the top shelf 153of the bottom plate 150, are machined to a sufficient degree to providea substantially airtight seal therebetween without the need for a gasketor other element. The plates 100, 150 are relatively heavy, so that theydo not break, get knocked over, and creates a relatively airtight sealbetween the plates. There is approximately 0.015 inches between theouter portion of the ridge 154 and the side wall 114 of the top plate100. In addition, a metal cover can be provided which covers the topplate 100. The cover is larger than the top plate 100, preferably with adiameter of 4⅝ inches, so that it can be easily removed from the topplate 100. The cover prevents particles from entering the device 50 whenit is not being operated.

The foregoing description and drawings should be considered asillustrative only of the principles of the invention. The invention maybe configured in a variety of shapes and sizes and is not intended to belimited by the preferred embodiment. Numerous applications of theinvention will readily occur to those skilled in the art. Therefore, itis not desired to limit the invention to the specific examples disclosedor the exact construction and operation shown and described. Rather, allsuitable modifications and equivalents may be resorted to, fallingwithin the scope of the invention.

1. A gas sampler device comprising: a top plate; a bottom plate having atop surface and a receiving portion at the top surface for receiving adish; a center well formed in the top surface of said bottom plate; and,a plurality of elongated slots formed in the top surface of said bottomplate, said plurality of elongated slots extending outward from saidcenter well beyond the receiving portion.
 2. The gas sampler device ofclaim 1, further comprising a ridge projecting upward from the topsurface of said bottom plate, said ridge defining the receiving portion.3. The gas sampler device of claim 2, wherein the plurality of elongatedslots extend into said ridge.
 4. The gas sampler device of claim 1,further comprising a gas passageway formed in said bottom plate, saidgas passageway in flow communication with said center well and extendingthrough said bottom plate to outside said bottom plate.
 5. The gassampler device of claim 4, further comprising a vacuum port in flowcommunication with said gas passageway, said vacuum port connecting to avacuum tube.
 6. The gas sampler device of claim 1, further comprising aplurality of holes located in said top plate.
 7. The gas sampler deviceof claim 1, wherein said top plate has at least one side which hasridges and said bottom plate has at least one side which is smooth. 8.The gas sampler device of claim 1, wherein gas is drawn in to saiddevice through said top plate to impinge on the dish and travel throughsaid plurality of elongated slots into said well.
 9. The gas samplerdevice of claim 1, wherein the gas comprises air.
 10. A gas samplerdevice comprising: a top plate having a top surface and a plurality ofholes; a bottom plate having a top surface and a ridge projecting upwardfrom the top surface, said ridge defining a receiving portion forreceiving a dish; a center well formed in the top surface of said bottomplate; a plurality of elongated slots formed in the top surface of saidbottom plate and extending outward from said center well, each of saidplurality of elongated slots having a proximal end in flow communicationwith said center well and a distal end in the ridge beyond the receivingportion; a gas passageway formed in said bottom plate, said gaspassageway in flow communication with said center well and extendingthrough said bottom plate to outside said bottom plate; and, a vacuumport located outside the bottom plate and in flow communication withsaid gas passageway, said vacuum port connecting to a vacuum tube;wherein gas is drawn into said device through said top plate to impingeon the dish and travel through said plurality of elongated slots intosaid well.
 11. The gas sampler device of claim 10, said top plate havinga top surface with a depressed portion, wherein the plurality of holesare provided in the depressed portion.
 12. The gas sampler device ofclaim 10, wherein the plurality of holes comprise over 100 holes. 13.The gas sampler device of claim 10, wherein the plurality of holes eachhave a diameter of approximately 0.0070 inches.
 14. The gas samplerdevice of claim 10, wherein the entire said device can be sterilized byheat or steam.
 15. The gas sampler device of claim 10, wherein saiddevice is suitable for use in a controlled environment.
 16. The gassampler device of claim 10, wherein the entire said device is metal. 17.The gas sampler device of claim 10, wherein said device is substantiallyairtight.
 18. The gas sampler device of claim 10, wherein said devicedoes not have a gasket.
 19. A gas sampler device comprising: a top platehaving a plurality of holes, each of said plurality of holes having adiameter of less than 0.01 inches; and a bottom plate having a topsurface and a receiving portion at the top surface for receiving a dish,wherein gas is drawn into said sampler device through said plurality ofholes to impinge the dish.